V-PRO® 60 LOW TEMPERATURESTERILIZATION SYSTEMAPPLICATIONThe V-PRO 60 Low Temperature Sterilization System withVAPROX® HC Sterilant is a vaporized hydrogen peroxide
Sterilizer intended for use in the terminal Sterilization of properly
cleaned, rinsed and dried reusable metal and nonmetal
medical devices used in Healthcare Facilities. The preprogrammed Sterilization Cycles (Lumen Cycle, Non Lumen
Cycle and Flexible Cycle) operate at low pressure and low
temperature and are thus suitable for processing medical
devices sensitive to heat and moisture.
The V-PRO 60 Sterilizer’s Lumen Cycle can sterilize*:
1.

Instruments with diffusion-restricted spaces such as thehinged portion of forceps and scissors.

2.

Non-Lumened devices including non-lumened rigid andsemi-rigid endoscopes.

3.

Medical devices (including single, dual and triple
channeled rigid and semi-rigid endoscopes) with thefollowing configurations:1• Single or dual lumened devices with stainless lumensthat are  0.77 mm (~1/32") internal diameter (ID) and 410 mm (16-9/64") in length• Triple lumened devices with stainless lumens that are either:»  1.2 mm (~3/64") ID and  275 mm (10-55/64") in length»  1.8 mm (~5/64") ID and  310 mm (12-13/64") in lengthOR»  2.8 mm (~7/64") ID and  317 mm (12-31/64") in length*Validation studies for all lumen configurations were conducted using a maximumof 12 lumens per load. Hospital loads should not exceed the maximum numberof lumens validated by this testing. The validation studies were performed usinga validation load consisting of one instrument tray with instrument organizers
and mat and two pouches for a total weight of 11 lb (5.0 kg).

The V-PRO 60 Low Sterilizer’s Non Lumen Cycle can sterilize†:• Non-lumened devices including non-lumened rigid, semirigid and flexible endoscopes and non-lumened devices
with stainless-steel or titanium diffusion-restricted spaces
such as the hinged portion of forceps or scissors.
†The validation studies were performed using a validation load consisting of one
instrument tray with instrument organizers and mat and one pouch for a total
weight of 12 lb (5.4 kg).

The V-PRO 60 Low Sterilizer’s Flexible Cycle can sterilize‡:• One flexible surgical endoscope or bronchoscope with alight cord (if not integral to scope) and mat without anyadditional load.‡ The flexible endoscope may be a single ordual lumen device with Lumens that are of  1 mm (~3/64")
ID and  990 mm (38-63/64") in length.
‡The validation studies were conducted with one flexible endoscope, packaged
into a tray with silicone mat, instrument organizers and light cord (if not integralto scope) and no additional load.

(Typical only - some details may vary.)

NOTE: Single-Use, medical grade polyethylene (PE) and Teflon®**tubing†† with internal diameter 1 mm and length  4 m may besterilized in the Flexible Cycle. Up to 26 pieces of tubing with noadditional load may be sterilized.
**Teflon is a registered trademark of E. I. duPont de Nemours and Company.

†† Tubing claims have not been reviewed by the US FDA.

DESCRIPTION
The V-PRO 60 Low Temperature Sterilization System is specificallydesigned to only process goods using vaporized hydrogen
peroxide under vacuum conditions. The process is fully
automated, is compatible with a broad range of materials and has
rapid Sterilization Cycle times. There are no toxic by-products
created by the Sterilization Cycle – only water vapor and oxygen
are produced.
The V-PRO 60 Low Temperature Sterilization System is NOT
intended to process liquids, linens, powders or cellulosematerials.
The system utilizes specially designed, disposable, multi-use
cups (available separately) containing VAPROX HC Sterilant andis available with single door in either a counter or cart mounted
configuration.

The Selections Checked Below Apply To This Equipment
UNIT POWER SUPPLY❑ North America: 120 Vac, 1 phase, 60 Hz, 20 Amp❑ Europe/Asia: 230 Vac, 1 phase, 50/60 Hz, 10/8 Amp❑ Japan: 200 Vac, 1 phase, 50/60 Hz, 12 Amp

OPTIONS❑ Single Door, Counter Mounted❑ Single Door, Cart Mounted❑ IQ/OQ/PQ Protocol (10088229)❑ Seismic Tie-Down Kit (10084158)** Conforms to the California Code of Regulations.

Item ________________________
Location(s)_______________________________________________
SD995 (06/01/16)

Articles to be sterilized are placed on a racking system within
the aluminum chamber. An automated control enables thecycle to be started and monitored by the operator. The touch
screen is user friendly and easy to operate.

HMI Control Display

ImpactPrinter

System installation requires no plumbing, ventilation or air
supply – only a dedicated electrical connection is needed. A
power cord is supplied for this connection.

STANDARDS

CupInterface

This V-PRO 60 Low Temperature Sterilization System meets theapplicable requirements of the following standards, as certified
by INTERTEK Testing Services:

Chamber Door Handle• Underwriters Laboratories (UL) Standard UL 61010-1
Second Edition• Canadian Standards Association (CSA) CAN/CSA 22.2
No. 61010-1 Second Edition

The proprietary cup is equipped with a data matrix code toensure the correct cup is used in the sterilization unit and thatthe cup contents are not expired; no cup code (or otherinformation) needs to be entered by the user.

Governing Directive for the affixing of the CE mark:• Medical Device Directive (MDD) 2007/47/EC
Standards applied to demonstrate conformity to thedirectives:

There are two Cup options available:• EN 61010-1, EN 61326-1:2006, EN 14937• IEC 61010-2-040
Each sterilization system is designed, fabricated, assembled
and tested in accordance with all applicable sections of UL andCSA.

• Ground Shipped (good for approximately 20 Cycles)• Air Shipped (good for approximately five Cycles)
Once Cup is punctured by the Sterilization System, it has a 14day “in Unit” shelf life. After use, empty Cups may be disposedin regular waste.

SIZE (W X L X H)

Catalytic converter receives outflow from chamber during all
cycle phases. Catalytic converter converts hydrogen peroxide
into water vapor and oxygen.

Overall Sterilizer Dimensions:• 31 x 31 x 28" (787 x 787 x 711 mm)
Chamber Size:

Other Components:• 13 x 28 x 10" (330 x 711 x 254 mm)

The following are furnished to obtain a complete working unit,
ready for (but not including) connection to the facility service
lines:

Chamber Volume:• 2.1 cubic feet (60 L)• Resistance Temperature Detectors (RTDs) are installed
for sensing and displaying temperature control of vaporizer
and chamber. Signals from all system RTDs, converted
into electrical impulses, provide accurate control inputs
and readouts throughout the entire cycle.

FEATURES
The chamber and door assembly are aluminum equipped witha silicone rubber gasket for the door and a welded backhead
for the chamber.

• Pressure Transducers are installed for sensing anddisplaying chamber pressure control. Signals from all
system pressure transducers, converted into electricalimpulses, provide accurate control inputs and readouts
throughout the entire cycle.

Insulation fitted on the chamber wall exterior, door andbackhead is 1/2" (13 mm) thick (nominal). Insulation is held inplace with adhesive.
Insulation is constructed of asbestos- and chloride-free, oil andwater resistant (silicone impregnated) fiberglass.

• Solenoid Valves and Switches are used in thesterilization system design to simplify piping and increase
serviceability.

Automatic door locking mechanism keeps the sterilization
system door locked during the entire Sterilization Cycle. After
cycle completion, the door is electrically unlocked. The sterilizer
door cannot be opened if electrical power is lost during sterilizer
operation. When sterilization system is in Standby mode, there
are no door opening restrictions.

• Chamber Air Supply and Vacuum Filters are supplied toensure air entering chamber is High Efficiency Particulate
Air (HEPA) filtered (prevent chamber recontamination) andair exhausted from vacuum pump is free of entrapped oiland odor.

Chamber heating is achieved through electric strip heaters
attached to the chamber sides, bottom wall, door andbackhead. Operating temperature is approximately 122°F(50°C).
Sterilant cup interface only accepts VAPROX HC Sterilant
Cups. The system control automatically tracks the amount ofVAPROX HC Sterilant used and the Sterilant expiration date.
The control prompts the user on the control display when a newcup is needed.

• High Power Vacuum Pump produces cycle vacuum
pulses that remove air and moisture from chamber. The
direct drive rotary vane pump is quiet (56 dB) with low
vibration. A powerful 1.0 HP (0.75 kW) motor produces adisplacement of 21 CFM (35 m3/hr) and helps alleviate
moisture sensitivity in the sterilization unit. The Sterilizer
operating pressure is from atmospheric pressure down toless than 1 Torr.
2• Sterilization System Panels are constructed of plastic.

• AERATION – This cycle phase pulls a vacuum to setpointand continues to evacuate for programmed time to reducechamber vapor concentration. Once Aeration phase iscomplete, chamber pressure returns to atmospheric andchamber door is unlocked.

• Sterilization System Frame and support system isconstructed of welded carbon steel with protective paint.

CONTROL DESCRIPTION
The V-PRO 60 Low Temperature Sterilization System isequipped with a proprietary control system and an impactprinter.

PREVENTIVE MAINTENANCE
Customers are encouraged to contact STERIS concerning
annual maintenance programs. Preventive maintenance,adjustments and replacement of worn parts are provided on ascheduled basis to help ensure optimal equipment
performance and help minimize untimely and costlyinterruptions. STERIS maintains a worldwide staff of wellequipped, factory-trained technicians to provide theseservices, as well as on-site installation, training and expert
repair services. Contact STERIS for details.

• Control Display Panel is located on the front of thesterilization unit in the center while facing the unit. Thiscolor touch panel provides user information and allows
user inputs. The display is a 640 x 480 pixel resolution,
5.7" screen. Use of this panel and associated screens isnormally self-explanatory. The screens are color coded foroperator convenience as follows:» Control Screens: Condition Phase - Green, Sterilize Phase- Blue and Aeration Phase - Violet

Some of the V-PRO 60 Low Temperature Sterilization Systempreventive maintenance is usage-based. Vacuum pumppreventive maintenance is due every 750 cycles or six months.
An oil can (yellow) appears on the screen when it is almost due
for maintenance. Can changes to red when maintenance isrequired.

» Service Screens - Light Blue
» Option Screens - Purple» Alarm Screens - RedNOTE: This Sterilization System permits no manual controlof the Sterilization Cycles.
The Ready, Status, Standby and Cup Empty screensinclude a cup level indicator (similar to a cell phone batteryindicator) in the lower right corner. For normal operation(with VAPROX HC Sterilant), each bar represents
approximately five cycles remaining (e.g., four bars meanscup contains enough sterilant for 16-20 cycles).

NOTES
1. For general installation information, refer to STERIS General
Notes for Sterilizers (drawing 062941-091). This drawing
should always accompany the equipment drawing.
2. Refer to equipment drawing showing all utility and spacerequirements for actual installation specifications.
Clearances shown are minimum required for servicing
equipment. Floor surface must be hard and level.

• Printer is located on the front of the sterilization unit on theright side while facing the unit. This alphanumeric impact
printer provides an easy-to-read permanent record of theSterilization Cycle. Printer provides a 2-1/4" (5.7 mm), 24character wide cycle tape and paper take-up.

3. STERIS recommends maintaining and operatingsterilization system in area where temperature does notexceed 86°F (30°C). Per AAMI ST58:2013, it is also
recommended to have a ventilation system exchanging
area air at least 10 times per hour.

CYCLE DESCRIPTION
The V-PRO 60 Low Temperature Sterilization System isequipped with three pre-programmed Sterilization Cycles:
Lumen Cycle (approximately 60 minutes to complete),
Non Lumen Cycle (approximately 28 minutes to complete) andFlexible Cycle (approximately 38 minutes to complete). Each
Sterilization Cycle proceeds through three phases:
CONDITION, STERILIZE and AERATION.

4. STERIS recommends a dedicated, grounded electricalcircuit be provided for each unit. Use of an extension cord
is not recommended.
5. Consult SDS regarding storage and handling of VAPROXHC Sterilant Cups.
6. Approximate unit weight – 120 Vac units: 255 lb (116 kg);
230 Vac units: 259 lb (117 kg).

• CONDITION – This cycle phase consists of the reservoir
filling and a timed vacuum pulse to remove air andmoisture from the chamber. When setpoint is reached,load is tested for acceptable moisture content. If content isacceptable, cycle proceeds. If not, Condition pulse
repeats.

7. Approximate cart weight – 255 lb (116 kg).
8. Heat loss at 70°F (21°C) – Peak = 271.10 BTU/hr;
Avg. = 95.83 BTU/hr.
9. Electrical Consumption, per cycle = 1.0 kW-hr average;out of cycle = 0.4 kW-hr average.

NOTE: If Condition phase fails the third moisture check, thecycle Aborts.

10. STERIS assumes no responsibility for changes to theSterilizer made necessary through failure to observe thesupplied necessary specifications (e.g., incorrect facilitypower supply).

• STERILIZE – This cycle phase is a series of four pulses.
Each pulse consists of: vacuum pulled to setpoint; VAPROXHC Sterilant vapor drawn into chamber; hold forprogrammed time; filtered air is introduced to setpoint; holdfor programmed time; deep vacuum pulled to setpoint.
3

EQUIPMENT DRAWINGS (REQUIRED FOR INSTALLATION)
Equipment Drawing
Part Number

Equipment Drawing Title

129603-007

V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM

Dimensions are typical.

Dimensions are in inches [mm]Drawing is not to scale.
PLAN VIEW

15-29/32[404]
Door Swing
14-3/8[365]

FINISHED
WALL

10-29/32[277]

105° Maximum Door Swing

FINISHEDWALL

CL CHAMBER

32-1/8[816]
35-1/8[892]

toN

noitalla
CL CHAMBER

tsn
Ir
Fo

64-1/2[1638]OverallHeight

CL CHAMBER

45-1/4[1149]
CL CHAMBERFINISHED FLOORFINISHED FLOORFRONT VIEWSIDE VIEWSINGLE DOOR, CART MOUNTED SHOWNFor Further Information, contact:
CUSTOMER IS RESPONSIBLE FOR COMPLIANCESTERIS Corporation
5960 Heisley RoadMentor, OH 44060-1834 • USA
440-354-2600 • 800-548-4873
www.steris.com

SD995 ©2016, STERIS Corporation. All rights reserved. (06/01/16)

WITH APPLICABLE LOCAL AND NATIONAL CODESAND REGULATIONS.

This document is intended for the exclusive use of STERIS Customers, includingarchitects or designers. Reproduction in whole or in part by any party other thana Customer is prohibited.